Upfront Surgery Vs Induction Chemotherapy Followed By Surgery In Oral Cancers:

PHASE3RecruitingINTERVENTIONAL
Enrollment

346

Participants

Timeline

Start Date

December 20, 2024

Primary Completion Date

October 31, 2027

Study Completion Date

October 31, 2029

Conditions
Oral CancerHead and Neck Neoplasms
Interventions
COMBINATION_PRODUCT

TPF or TPX Regimen (2# ICT) --> Surgery and Adjuvant Treatment

"TPF:~IINJ DOCETAXEL 75mg/M2 in 500 ML NORMAL SALINE(PVC free container/glass bottle) via codon filter OVER 60 MIN (DAY 1 ONLY) INJ. CISPLATIN 75 MG/M 2 IN 500 ML NS IV OVER 1 HOUR ON DAY1 ONLY INJ. 5FU 750 MG/M2 IV THROUGH INFUSION PUMP OVER 24 HOURS D 1-4~Or~TPX Regimen INJ DOCETAXEL 75mg/M2 in 500 ML NORMAL SALINE(PVC free container/glass bottle) via codon filter OVER 60 MIN (DAY 1 ONLY) INJ. CISPLATIN 75 MG/M 2 IN 500 ML NS IV OVER 1 HOUR ON D1 ONLY TAB. CAPECITABINE 850-1000MG/M2 TWICE A DAY 30 MINUTES AFTER MEALS FOR 14 DAYS IN A THREE WEEKLY CYCLE~Surgery and Adjuvant Treatment Patients with PR/CR or SD will go for surgical resection. Patients having PD but still localized and resectable will be offered surgical resection, other would undergo radical CTRT or Palliative Treatment."

COMBINATION_PRODUCT

Surgery and Adjuvant Treatment

Wide Local Excision (WLE) with Comprehensive neck dissection and Adjuvant Treatment as per current standard Guidelines.

Trial Locations (7)

342005

RECRUITING

All India Institute of Medical Sciences, Jodhpur, Jodhpur

751019

NOT_YET_RECRUITING

All India Institute of Medical Sciences, Bhubaneshwar, Bhubaneshwar

Unknown

NOT_YET_RECRUITING

All India Institute of Medical Sciences, Bathinda, Bathinda

NOT_YET_RECRUITING

Shri Mahant Indresh Hospital, Dehradun, Dehradun

NOT_YET_RECRUITING

King George's Medical University, Lucknow

NOT_YET_RECRUITING

All India Institute of Medical Sciences, Rishikesh, Rishikesh

NOT_YET_RECRUITING

Geetanjali Medical College, Udaipur, Udaipur

All Listed Sponsors
collaborator

All India Institute of Medical Sciences, Rishikesh

OTHER_GOV

collaborator

All India Institute of Medical Sciences, Bhubaneswar

OTHER

collaborator

All India Institute of Medical Sciences, Bathinda

OTHER_GOV

collaborator

King George's Medical University

OTHER

collaborator

Shri Mahant Indiresh Hospital, Dehradun

UNKNOWN

collaborator

Geetanjali Medical College, Udaipur

UNKNOWN

lead

All India Institute of Medical Sciences, Jodhpur

OTHER_GOV